MINERALYS THERAPEUTICS INC (NASDAQ:MLYS) Beats Q3 2025 EPS Estimates and Advances Key Drug Candidate

MINERALYS THERAPEUTICS INC (NASDAQ:MLYS) reported its third quarter 2025 financial results, delivering an earnings per share figure that surpassed analyst expectations. The clinical-stage biopharmaceutical company, which focuses on developing treatments for conditions driven by elevated aldosterone, continues to operate without revenue as it advances its lead drug candidate through clinical trials. The market's initial reaction showed modest downward pressure in after-hours trading, though the stock has demonstrated relative stability over recent weeks.

Earnings Performance Versus Estimates

The company's financial results for Q3 2025 reflect its ongoing clinical development phase, with no product revenue generated. The key financial metrics compared to analyst expectations are:

• Earnings Per Share (EPS): Reported -$0.52 versus an estimated -$0.63
• Revenue: Reported $0.0 million, matching the estimate of $0.0 million

The narrower-than-expected loss is the primary financial highlight from the quarter. This outperformance on the bottom line suggests the company is managing its operational expenditures effectively while progressing its clinical programs. The absence of revenue was anticipated, as the company's lead product candidate, lorundrostat, remains in development and has not yet been submitted for regulatory approval.

Market Reaction and Recent Performance

Following the earnings release, MINERALYS THERAPEUTICS INC experienced a slight decline in after-market trading. This immediate reaction may reflect profit-taking after recent gains or a "sell the news" dynamic, rather than fundamental disappointment, given that the company beat the EPS estimate. The stock's performance over broader timeframes provides additional context:

• After-Market Performance: -2.25%
• Last Week Performance: +0.14%
• Last Two Weeks Performance: +0.10%
• Last Month Performance: +0.03%

The minimal movements over the past month indicate a period of consolidation for the stock. The modest after-hours dip appears to be a minor adjustment rather than a significant shift in sentiment, especially considering the earnings beat.

Corporate Developments and Pipeline Progress

The earnings press release highlighted several critical milestones for Mineralys Therapeutics, which are arguably more significant to its long-term valuation than its current financials. The company provided updates on its lead candidate, lorundrostat, an aldosterone synthase inhibitor being developed for hypertension and related conditions.

The most substantial news involves the regulatory and clinical timeline for lorundrostat. The company plans to submit a New Drug Application (NDA) to the FDA in late 2025 or the first quarter of 2026. This submission represents a crucial step toward potential commercialization. Additionally, the company announced it has completed enrollment in its Explore-OSA trial, which is investigating lorundrostat for patients with hypertension and obstructive sleep apnea. Topline results from this study are anticipated in the first quarter of 2026, setting up a series of important catalysts for the company over the coming year.

Financial Outlook and Analyst Expectations

Looking ahead, analyst estimates for the company's future financial performance align with its clinical-stage status. For the full year 2025, analysts project an EPS of -$2.74 and zero revenue. The forecast for the fourth quarter of 2025 is an EPS of -$0.62, also with no expected revenue. The company's press release did not provide its own financial guidance for these periods, making a direct comparison to analyst projections impossible. The lack of company-provided outlook is typical for biotech firms at this stage of development, where clinical progress is the primary driver of value.

Conclusion

Mineralys Therapeutics' third-quarter report presented a mixed but generally positive picture. Financially, the company beat EPS estimates while continuing to burn cash to fund its operations, which is standard for a pre-revenue biopharmaceutical company. The market's slight negative reaction in after-hours trading seems disconnected from the fundamental news of a narrower loss and significant pipeline advancements. The core of the investment narrative for MLYS remains firmly tied to the progress of lorundrostat, with the upcoming NDA submission and data readouts in early 2026 representing the most critical value-inflection points on the horizon.

For a detailed look at historical earnings and future analyst estimates for MINERALYS THERAPEUTICS INC, you can review the data here.

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